BEUDAMED
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    Wallace Oocyte Recovery Needles,Oocyte Recovery sets, 750 mm tube with flushing connector, Product Number: KLN-750, and KLN-750. Retrieval of Oocytes.

    FDA Recall
    Terminated ·Irvine Scientific Sales Co Inc·Product code MQE·October 23, 2008

    American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery.

    FDA Recall
    Terminated ·American Optisurgical Inc·Product code HQC·March 24, 2009

    Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium (K+) on VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics Inc·January 1, 2020

    Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)

    FDA Recall
    Terminated ·Freudenberg Medical, Llc·Product code DYB·February 21, 2022

    Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)

    FDA Recall
    Terminated ·Freudenberg Medical, Llc·Product code DYB·February 21, 2022

    Pathway Balloon Expandable Ureteral Access Sheath- 13/16/28, Ureteral dilator, Catalog Number: 255103; Product Number: M0062551030, Onset Medical, Boston Scientific Corp., Natick, MA 01760

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code EZN·November 30, 2007

    Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc. Covington, Georgia 30014 * 1-800-526-4455 * Sterile/EO

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code EZN·November 3, 2005

    Pathway Balloon Expandable Ureteral Access Sheath- 11/14/46, Ureteral dilator, Catalog Number: 255102; Product Number: M0062551020, Onset Medical, Boston Scientific Corp., Natick, MA 01760

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code EZN·November 30, 2007

    Pathway Balloon Expandable Ureteral Access Sheath- 12/15/46, Ureteral dilator, Catalog Number: 255108; Product Number: M0062551080, Onset Medical, Boston Scientific Corp., Natick, MA 01760

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code EZN·November 30, 2007

    Pathway Balloon Expandable Ureteral Access Sheath- 11/14/36, Ureteral dilator, Catalog Number: 255101; Product Number: M0062551010, Onset Medical, Boston Scientific Corp., Natick, MA 01760

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code EZN·November 30, 2007

    Pursuit ureteral dilation balloon catheters, 6 mm x 4 cm. Order # PAB-050080-6-4.0

    FDA Recall
    Terminated ·Cook Urological, Inc.·Product code EZN·January 22, 2003

    Pathway Balloon Expandable Ureteral Access Sheath- 12/15/36, Ureteral dilator, Catalog Number: 255107; Product Number: M0062551070, Onset Medical, Boston Scientific Corp., Natick, MA 01760

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code EZN·November 30, 2007

    Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200, manufactured by Stryker Endoscopy San Jose The intended use of the Stryker Vision Mount is to hold and position an LCD monitor. The Stryker Vision Mounting Arm can be used with any Stryker flat panel display and is It is compatible with Stryker Carts (0240099001, 0240099011 or 0240099020). It is indicated for use in a surgical operating room environment and is exposed to environmental conditions associated with the storage and shipping of the product. It is not intended to enter the sterile field. The Stryker Vision Mount does not deliver to and/or extract from the patient any energy or material. It does not process any biological materials, as it is not intended to be sterilized by the user. The Stryker Vision Mount is only used to display surgical images and video and does not sustain or support life.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code BZN·August 30, 2013

    Pathway Balloon Expandable Ureteral Access Sheath- 12/15/28, Ureteral dilator, Catalog Number: 255106; Product Number: M0062551060, Onset Medical, Boston Scientific Corp., Natick, MA 01760

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code EZN·November 30, 2007

    Pathway Balloon Expandable Ureteral Access Sheath- 13/16/36, Ureteral dilator, Catalog Number: 255104; Product Number: M0062551040, Onset Medical, Boston Scientific Corp., Natick, MA 01760

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code EZN·November 30, 2007

    InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard is a preventive aid for operative dentistry. It is used to protect adjacent teeth from iatrogenic preparation damage. This includes cavity and tunnel preparations as well as air abrasion.

    FDA Recall
    Terminated ·Ultradent Products, Inc.·Product code DZN·December 22, 2015

    Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufactured for: Stryker, 5900 Optical Court, San Jose, CA 95138, UDI: 07613327462784 - Product Usage: The Connect OR Cart is a mobile, medical-grade cart intended to store and transport components of minimally invasive and open-field imaging systems such as the Stryker Advanced Imaging Modality (AIM) System, PINPOINT Endoscopic Fluorescence Imaging System, or SPY Portable Handled Imaging (SPY-PHI) System) during intraoperative use. The Cart also provides power, video, and data connections to the components.

    FDA Recall
    Terminated ·Stryker Corporation·Product code BZN·April 23, 2019

    Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator, Catalog Number: 255100; Product Number: M0062551000, Onset Medical, Boston Scientific Corp., Natick, MA 01760

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code EZN·November 30, 2007

    Pathway Balloon Expandable Ureteral Access Sheath- 13/16/46, Ureteral dilator, Catalog Number: 255105; Product Number: M0062551050, Onset Medical, Boston Scientific Corp., Natick, MA 01760

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code EZN·November 30, 2007

    Pursuit ureteral dilation balloon catheters, 6 mm x 8 cm. Order # PAB-050080-6-8.0

    FDA Recall
    Terminated ·Cook Urological, Inc.·Product code EZN·January 22, 2003